This post from April 20th - updated below this part:
Will be doing my 13th Harvoni later on today. So far, not too bad. Insomnia has mostly been the worst for me - though I have had a history of it over the last couple of years. I feel pretty good on the days where I have gotten a good nights sleep and draggy on the ones that I don't. I sometimes have a feeling of being saturated by the Harvoni, a very chemical like feeling, and at times, feeling wired up.
Taking a regular walk in the evenings seems to help a great deal - I do know that I feel and sleep better if I can get out and do it. A lot of times I really don't feel like getting up off of the couch, but it seems that once I do start walking, after awhile, I feel pretty good. Sometimes I do jog for 50-100 yards at a time.
Drinking water is great - I have always drank mostly water in the past decade or so, but the Harvoni makes you crave it. I seem to want really cold water with ice. Unfortunately, last week my freezer stopped working correctly and I have no ice - and had to throw out some precious food. My landlord is dragging his heels on getting it fixed. The Harvoni also has given me an enormous appetite - I have noticed that eating fresh fruits and veggies and keeping away from any kind of heavy meals makes me feel the best. However, combined with the loss of the food from the freezer and current financial condition, I have had to eat whatever was left in my pantry. This is why I had wanted to wait to start Harvoni as I did not have to worry about not having food or supplies. Oh well, will just have to take it one day at a time.
SIDE EFFECTS of HARVONI - Lesser Known
In my previous post, I posted the side effects listed on the Gilead Canada site which were not on the Gilead USA site - still not there as of today. Does anyone know why the Canadian site would list sides while the USA site does not? I scan the many forums daily and see that many, many folks are reporting sides other than the nausea, fatigue, headache, and insomnia that are the most common. And many forums give the advice that these sides are not Harvoni related - but most are listed on the Gilead Canada site. I did mention the Gilead Canada site on one of the Facebook sites - one person looked it up and one of the moderators seemed to know about it but did not post it. What's the deal? Wouldn't you want to know that some of the sides that you are feeling are legitimate? And not in your head?
Less Common Clinical Trial Adverse Drug Reactions (less than 2%)
Adverse reactions (Grades 2 to 4) occurring in less than 2% of patients
receiving 8, 12 or 24 weeks treatment with HARVONI in clinical trials
are listed below by body system:
HARVONI (Ledipasvir/Sofosbuvir) Tablets
Product Monograph
Page 8 of 61
Table 2. Adverse Reactions (Grades 2 – 4) Reported in less than 2% of Patients
Receiving 8, 12 or 24 Weeks of HARVONIa from the Pooled Phase 3 Studies
(ION-1, ION-2, ION-3)
Blood And Lymphatic System Disorders - Factor VIII inhibition
Cardiac Disorders - Palpitations
Eye Disorders - Visual impairment
Gastrointestinal Disorders - Abdominal discomfort, abdominal
distension, abdominal pain, abdominal pain upper, constipation,
diarrhoea, dyspepsia, gastrooesophageal reflux disease, mesenteric vein
thrombosis, nausea, oral discomfort, vomiting
General Disorders And Administration Site Conditions - Asthenia,
feeling abnormal, irritability, edema
Hepatobiliary Disorders - Hepatitis acute
Infections And Infestations - Conjunctivitis infective, salpingitis,
sinusitis
Injury, Poisoning And Procedural Complications - Contusion, ligament
sprain, meniscus injury, muscle strain
Metabolism and Nutrition Disorders - Abnormal loss of weight, decreased
appetite, gout
Musculoskeletal and Connective Tissue Disorders - Arthralgia, joint
effusion, muscle spasms, muscular weakness
Nervous System Disorders - Disturbance in attention, dizziness, memory
impairment, migraine, migraine with aura, parosmia, somnolence
Psychiatric Disorders - Affect lability, aggression, anxiety, depressed
mood, depression, emotional disorder, insomnia, libido decreased, sleep
disorder
Renal And Urinary Disorders - Urinary retention
Reproductive System and Breast Disorders - Erectile dysfunction,
metrorrhagia
Respiratory, Thoracic and Mediastinal Disorders - Oropharyngeal pain,
sinus congestion
Skin And Subcutaneous Tissue Disorders - Acne, alopecia, hyperhidrosis,
prurigo, pruritus, rash
Vascular Disorders - Hemorrhage, hypertension
Gilead Canada:
http://www.gilead.ca/pdf/ca/harvoni_pm_english.pdf
Gilead USA:
http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/harvoni/harvoni_pi.pdf
(note, I removed the grid from the first posting and the Sovaldi info too)
As with any fairly new drug, new side effects will come to light - and it is our guinea pig duty to report them to Gilead and to our doctors. I know that my doctor did not mention any of these other possible sides.
Am posting this now but will add to it later. Off to scrounge for food for me, cat food and toilet tissue!!!!!!!!! I envy those with supportive families or the means to just concentrate on treatment not just surviving day to day.
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Updated April 25th
Back and just did # 17. Was able to get food and freezer seems to be working again. Disaster averted! Gee, this stuff makes you extremely hungry! And also gives you a sweet tooth. I have succumbed a couple of times and eaten some M and M's and felt pretty cruddy soon after. I have been trying to avoid as much sugar as possible for years anyway, but it really seems to be a no no with Harvoni.
I mentioned having to eat what I had in the pantry - one thing that I ran out of was olive oil. The decent stuff is a bit pricey but what a difference it makes! I love to make sweet potato fries and baked chicken and using vegetable oil to cook them with really messed with my stomach. I felt like I had sludge in my system the next day. The olive oil makes a tremendous difference to me and happily I have some!
I do get some bloating late at night before bedtime - but it is a different kind of bloating than the intestinal bloat from gluten - it goes away by the next morning.
Lets see, what else? I did wake up with an ugly purple blotch on my wrist - don't know if it is an indication that my platelets are a bit low? But I have had this happen in the past pre-Harvoni. And a history of slight vasculitis. And sometimes it feels like my lower legs are made of cement, like now. Walking helps that feeling and it goes away. Am about to go walk now - I have a neighborhood route that takes me up next to some railroad tracks - there is a lot of sand mixed in and it feels like my legs get a good workout from walking on it.
I do have dryer skin, even with the almost gallon of water a day that I drink - and some itchiness. Using fragrance free Whole Foods type moisturizers help both the dryness and itch. By no means use crap like Vaseline Intensive Care lotion! It is nothing but chemicals which is the last thing your skin and system need. Just like with food, read all ingredients that are in your body care products and stuff like shampoos, etc.
I was troubled at first that my walks happen soon after I take the Harvoni - didn't know if the stuff would give me a heart attack or stroke if I exercised so soon after taking it, lol. But no problems.
I did quit the milk thistle after all. I took it in the first week but 12 hours away from the Harvoni. But am still doing the LDN twice a week - again 12 hours away from the Harvoni. The pharmacy told me that it was ok to take but I had to spell Naltrexone for them. So I have no confidence that they have any idea of how Low Dose Naltrexone works.
That's all folks - it's Jazz Fest time in NOLA - although a wet one so far - THE WHO and John Legend are playing now. Not that I have the bucks to go - oh well, maybe next year!
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Updated Tuesday April 28th
Day 21 - Three weeks down - 5 weeks (35 days) to go! The specialty pharmacy called yesterday and my last bottle of Harvoni is coming on Thursday. But thank god this is only a two month go round!
Had cruddy weekend - did not sleep well last 3 nights - was very tired and achy all day Sunday - I think very rainy weather has attributed to overall feeling.
I had mentioned a very overactive bladder from the first night on. I do drink a lot of water, as well as Smart Water type drinks (no sugar) so I thought that maybe that was the reason for having to go to the bathroom every 15 minutes. But this seems to have gotten worse and I feel like there is pressure on my kidneys.
I have always tested perfect in every kidney type test that I have ever had. But I decided to call my own doctor to report this - however, over at LSU, it is often difficult to reach him or his nurse. I needed to call them anyway to see if I am supposed to have 4 week labs done. Had to leave message and have not heard back from them so far.
So then, I called the Gilead Support Path - I have heard great things about this as they have helped so many people navigate the Harvoni highway and arranged for folks to receive the Harvoni. A few people mentioned the 24/7 Nursing Support Line, so I called them a little while ago.
The first thing that they asked is if I called my own doctor. Because, excessive urination is not a Harvoni problem. Oh, funny how the excessive urination began on day one of Harvoni and has continued on to day 21. Well, this kind of set me off. I asked the woman if Harvoni only caused headache, fatigue and nausea as described on Gilead's American site and on most other drug description site? And she pretty much said yes. I told her that so many people on the forums are reporting so many different sides - seems it must be their imagination - like it is mine.
Then I mentioned the Gilead Canada site and she said that she was not aware of it. And that they were not allowed to go to it as a reference point. OK - so now, I suppose that the Harvoni made at Gilead Canada is different than the Harvoni made by Gilead in the United States? Why do these assholes list three side affects in the United States and 100 in Canada? Wouldn't these "health care professionals" want to know all possible sides so that they could actually help people? Of course not.
Just venting today - and being pissed. Yes, I am happy to have the opportunity to finally get rid of this virus. For many people with liver transplants or cirrhosis - or for those who have gone through several previous brutal treatments and failed them all or had the virus come back, it is a godsend. But for someone like me who had little symptoms and great numbers (thanks to LDN, diet and supplements) I feel like I drank the Kool Aid. And as I said earlier in the year on this blog, I really would have preferred to wait until next year to do this.
Well, hopefully I will feel better again - worrying about impaired kidney function and probably reading too many forum posts from people who have completed treatment, are undetectable but still feel like crap months later.
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UPDATE: Friday May 2nd, 2015 - Day 25
Called and left several messages for doctor and was told that the clinic would get back to me. Still waiting. I did hear that they will run labs after 30 days. Don't know what kind - probably CBC and hopefully Viral Load. Guess that if I have any more sides, I will have to go to Urgent Care or the Emergency room. Not a good feeling to know that your doctor is not there for you. Feeling pretty alone. Still have frequent urination and a variety of other minor sides. Day 25
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UPDATE TUESDAY MAY 5, 2015 - Day 28
Saturday morning I woke at 6:30 to go to the estate and garage sales as usual (I sell books online). I felt awful, exhausted, brain fog, headachy and weak. I had felt fine the night before. I walked to the bathroom and felt dizzy. Then, said the hell with it and went back to sleep. Got up a couple of hours later and felt well enough to function - not bad but not good. Just dragged around all day. Sometimes in the morning, I feel cruddy with a slight headache - but once I do get up and have a cup of coffee or two, the headache is gone and I feel much better. Saturday morning was not like that.
But, the last two days, I slept really well, and have felt pretty good - You just never know with this stuff! And the constant need to urinate has gotten a tad better. I think that my diet might somehow affect it - or whatever is causing my stomach/bladder/whoknowswhat? to swell out. As mentioned earlier, since I haven't eaten wheat in 7 years, it is different kind of bloat than a "gluten bloat." I had been eating a lot of cheese and more dairy products than I had been - I cut back on them and the bathroom visits have diminished. But who knows?
The good news is that the nurse finally got back to me yesterday - and she finally consulted with the doctor and ordered labs. I did them earlier today - CBC/HCV-RNA(or whatever test they use for viral load) and had a urinalysis done. I had wanted to fast before the labs for the CBC but didn't make it - this morning was a "coffee morning." And wish that I'd known about the urinalysis beforehand - the B vitamins colored the sample. Oh well. The hell with the CBC! I want to know if the Harvoni is working and if I still have a viral load - or???????????????
Guess I'll find out in a couple of days - LSU has a Patient Portal - but of course, it isn't working right now. I will post the results soon! Taking pill @28 in a little while - Starting second and last bottle tomorrow.
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UPDATE SATURDAY MAY, 9TH
Day 32. I had hoped to be able to post 30 day labs - however, although the nurse told me on Thursday that they did get in my results, the doctor needed to look at them. And that he would call me. Which of course, he did not. Spoke with nurse again on Friday and was told that doctor wouldn't be back until Monday. So no big deal - just wondering if the virus that I've had for 40+ years is still around.
Have had enormous, ridiculous appetite - ate almost a whole jar of peanut butter the other day. Have gained at least 5 pounds, and now have belly gut. Looks almost like ascites. But I guess if anything was really out of whack, it would have shown up in the CBC and the urinalysis. I hope. Meanwhile, this is a drag - feel ok but not comfortable in my own skin.
Will be seeing doctor on Monday afternoon. He will hear about the side effects which are a hell of a lot more than the usual, "fatigue, headache, insomnia" quoted on Gilead's US site - and repeated ad nauseam by ill informed/arrogant doctors.